Mesalamine

Product NDC
72162-1804
11-digit product format
721621804
Labeler code
72162
Product ID
72162-1804_f9f95283-e509-42a4-bcdf-f471c0bac950
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mesalamine
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Bryant Ranch Prepack
Application
ANDA207448
Marketing category
ANDA
Marketing start
2019-06-05
Marketing end
2026-10-31
Substance
MESALAMINE
Active strength
1000 mg/1
Pharmacologic classes
Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mesalamine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MESALAMINE1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Q81I59GXC
Rxcui248420

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c403bb07-2e2f-647c-b633-3f06ae7ddbe3Product name320260128
37997c2c-8686-b078-51f1-fb15da0c0a1cProduct name620260127
97851e97-0a12-4d74-aaa4-9583fe070304Product name220250318
194d5e54-52c4-1a5e-51c5-1224f8e44e49Product name520250317
4b8d62b1-86bf-0c4e-9f22-ebffb45e4564Product name520240514
f6c01aa7-7e2c-4709-91b6-fc6ece37a7b3Product name120230124
a4dbd90c-f616-c999-40d7-60da88952163Product name220190802
77831c26-5062-ed63-fc15-a07600377b5bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1804-1Mesalamine5 in 1 CARTONSUPPOSITORY5101
72162-1804-1Mesalamine6 in 1 PACKAGESUPPOSITORY6101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1804-3EA - Each72162-18043bc0c326-791a-4f27-8dd6-f1948715feb612024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1804MESALAMINE SUPPOSITORY [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20241122_b48df65a-a717-479e-9122-8b0f1406c841.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248420mesalamine 1000 MG Rectal SuppositoryPSNb48df65a-a717-479e-9122-8b0f1406c841101
248420mesalamine 1000 MG Rectal SuppositorySCDb48df65a-a717-479e-9122-8b0f1406c841101
248420mesalazine 1000 MG Rectal SuppositorySYb48df65a-a717-479e-9122-8b0f1406c841101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72162-1804-1721621804015 PACKAGE in 1 CARTON (72162-1804-1) / 6 SUPPOSITORY in 1 PACKAGE5 package2019-06-052026-10-31NoNoHistorical